What Defines a Medical Device?

Before we discuss what constitutes a medical device, it’s a good idea to start by considering why having such a definition is necessary.

Medical devices can be used to treat patients suffering from a wide variety of conditions — everything from a small cut to a life-threatening illness. Without proper regulation, there is no way of knowing whether these devices are of an appropriate quality or are being used as intended. This lack of knowledge can harm both patients and clinicians.

With that in mind, the Therapeutic Goods Association (TGA) plays a vital role in protecting doctors, nurses, patients, and those companies that develop and manufacture medical devices.

As per their definition, a medical device must meet the following criteria:

• Be used for humans.
• Be used with the intention of diagnosing, preventing, monitoring, treating, or alleviating a disease or injury, OR, modifying or monitoring anatomy or physiological functions of the body.
• Generally achieve its purpose by a physical, mechanical, or chemical action.

Within this definition, a medical device can be further classified based upon its intended purpose and perceived risk to the patients. In classifying a device, the TGA also takes into account how invasive the product is, and whether it requires a source of energy to function. These classifications can be summarised as follows:

• Class I: Risk level — low. Example, surgical retractor.
• Class I — supplied sterile: Risk level — low-medium. Example, hypodermic needles.
• Class I — incorporating a measuring function: Risk level — low-medium. Example, a medicine cup.
• Class IIa: Risk level — low-medium. Example, an infrared thermometer.
• Class II b: Risk level — medium. Example, a blood bag.
• Class III: Risk level — high. Example, a major joint replacement.
• AIMD: Risk level — high. Example, an implantable defibrillator.

Role of the TGA

The TGA plays an essential role in making sure that medical devices are safe from the perspective of both the clinician and the patient.

As part of this, they have developed a list of Essential Principles, which must be met before a medical device can be manufactured, marketed, and sold in Australia. These Principles are far reaching and concern themselves with all stages of the medical device production process, including research and development, manufacturing, marketing, and use.

It’s important to note that once the TGA has approved a medical device, their role does not end. Rather, they continue to monitor devices that are on the market to ensure that the benefits of a product outweigh any potential risks associated with using it.

Paragon Care’s Portfolio of Medical Devices

As a leading provider of medical devices, Paragon Care is inherently familiar with the role of the TGA and our associated responsibilities to the healthcare community. Our product portfolio boasts an extensive range of high-quality medical devices and we provide support to healthcare workers across all specialties.

If you have any further questions regarding our range of products, we encourage you to get in contact with our team of trained customer service professionals today.